Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
CalMUSTANG
Do you have any updates on the generic court case with AMARIN..... the response to the new motions presented on 08-30-2019 were to be heard today...
HDGABOR:
Could it also be based on "HOW" i.e .... what is the MOA (method of action) pertaining to the results.... the FDA will always keep the statin players in their rear view mirror...
HD:
As you state in your post #210745, dated 08-23-2019.... the FDA should have contacted AMARIN on scope of ADCOM ... You asserted around 08-28-2019... I contacted IR on 09-02-2019....would not answer receiving communications with FDA...or draft question, since they are in ongoing talks....
You stated approx. 10-14/24-2019 the FDA to send Amarin briefing docs and DRAFT QUESTION for review ... with ongoing communications between the two, but final agreed to DOCS about 11-01-2019 to be prepared for public release....
On 11-12-2019 FDA /Amarin will post available briefing materials..
We are close in dates, but getting a copy of briefing materials and draft question would let us know if FDA is going to pull the same shenanigans as in previous ADCOM... we need to pepper AMARIN and anyone else to obtain some information, before we see some big PUT OPTION...
HD, please let us know how to avoid what took place 6 yrs ago ????
Timing .....
1. 74 day letter was expected to be sent to Amarin ( electronically ) around SEPT 2,2019... asked IR but would not confirm.... this letter lets Amarin know why ACCOM was requested and general areas of discussion....
2. Briefing Docs to be electronically sent to Amarin 14 days before Adcom to finalize what the committee would be discussing ..... defining scope of Adcom....
2. 48 hours before Adcom ...What the voting question will be .... this is where the FDA changed the voting question ( moving the goal posts ) at last Adcom in 2013...
The Briefing Docs are so important, and if we could get a copy, we would have some idea of what we are against as investors... soliciting them by this board would be HUGE....
Was trying to keep this board informed, so that they may make informed decisions going forward !!!
NORTH40000
I agree with you 100%.....I have read the patents only.... I have already stated that how the patents were reviewed by USPTO, all the meetings with FDA, etc. was not under my purview.... I stated that the judge would make the final rulings....
I was only summarizing the motion presented to the court by the GENERICS...on 08-30-2019
STS66
Please do some DD before adding your two cents.... like read the motion.... your post lacks the factual info I and MELLOWOOD submitted in our posts...
You would do well to apologize...
I agree....AMARINS legal team will dispose this argument by GENERICS as having no merit, but the judge may let it proceed to trial in JAN. 2020.....the judge will ask both parties to settle before trial...
Yes I am....
I believe that AMARINS patents are strong.... I believe that AMARINS legal team will defeat this defense by the GENERICS.... BUT the GENERICS had to come up with some defense to invalidate AMARINS patents and this is a novel approach..... AMARINS response due Sept.13,2019......
NO....
The GENERICS presented their witness and AMARIN presented their witness at the depositions.... to discuss OBVIOUSMENT and NONOBVIOUSMENT......
The GENERICS are using AMARINS witness testimony of NONOBVIOUSMENT against itself for "written description" in the patents....
GENERICS are citing " WRITTEN DESCRIPTION " in the patents as defense to invalidate the MARINE patents..... thats it... defeat that and AMARIN wins their court case against the GENERICS...
HDGABOR/BIO
Is the 74 day letter due out on Sept.2,2019 to Amarin to inform them of what potential areas are to be discussed at the ADCOM.....In order to let Amarin start their preparations....
The generics witness did discuss OBVIOUSNESS and how epa/dha had studies ( and drugs) done in the market for over two decades..... BUT AMARINS witness talked how it was NONOBVIOUS to know how the drug VASCEPA would work and what the results would be from the MARINE TRIAL.....
The generics are using AMARIN'S witness presenting NONOVIOUSNESS as their way to invalidate the MARINE PATENTS since the patents were written before the twelve week study was done and results published.... using "WRITTEN DESCRIPTION" as their sole case...
The GENERICS are pinning their whole case on this particular area and its up to AMARIN'S legal team to refute "WRITTEN DESCRIPTION" in their patents...
Their were many legal cases cited to set precedent by the GENERICS.... This case will go to court and maybe appeals court, etc.
The generics are looking for a LOOPHOLE.... and may have found one.... not right, but may be legal... hopefully AMARIN'S legal team knows this was coming and may already be prepared for it...
Everything you mention in this post plus additional information was stated in AMARIN'S expert witness deposition ( DR TOTH ) to support AMARIN'S claim of NONOBVIOUSNESS ..... meaning no one could know the results, therefore it could not be OBVIOUS...
But the GENERICS are stating that that AMARIN had to claim in their patent submittal a written description ( that the drug would reduce trig's, raised apo3, lowered ldl, etc.) .... AMARIN could have known the results they were looking for when running the MARINE STUDY, to be used to get NDA approval for VASCEPA, but did not specify them in the MARINE patents submitted....
The patent wording, the USPTO clarifications in submittals, the FDA SPA concerning REDUCE-IT STUDY PARAMETERS, ETC.all worked on in yrs 2008/2009 will be looked at.... to clarify "WRITTEN DECSRIPTION" in MARINE PATENTS...
To answer your question....
Generic companies fight patents by citing invalidity by OBVIOUSNESS,ANTICIPATION, ENABLEMENT, OR INDEFINITENESS..... TEVA is in trouble financially and does not have the funds to fight patents, so they accepted payment from AMARIN for legal costs and will wait until yr 2029....BUT if the other generics win the patent case, they will also begin selling the drug....
GENERIC CASE as of today:
1. AMARIN filed motion for partial summary judgement on 08-01-2019, citing results from depositions taken from Generics concerning obviousness, enablement, anticipation,indefinitiveness .....
2. GENERICS filed motion for final summmary judgement to have AMARIN'S partial summary denied on 08-01-2019....
3. Court to provide decision on 08-30-2019 on both motions....
4. GENERICS filed new motion on 08-30-2019 to have AMARIN'S partial summary motion denied citing that they would not fight patents concerning obviousness, anticipation, indefiniteness thus making them moot ( exactly what AMARIN was looking for ).... AMARIN knew they would be fighting OBVIOUSNESS since the GENERICS brought in an expert witness to the depositions for that claim......
5. GENERICS looking for AMARIN'S patents to be invalid for OBVIOUSNESS OR NONOBVIOUSNESS .... thus they win either way ... no trial in January needed... so to speak off .... if AMARIN fights obviousness they go to nonobviousment because AMARIN didn't cite written description in their patent... but GENERICS cited numerous court cases concerning WRITTEN DESCRIPTION in patents in this new motion...
6. AMARIN will probably be given time to refute these new assertions.... hard to believe their legal team didn't know about obviousness or nonobviousness ramifications... having GENERICS only bring in one expert witness during deposition concerning OBVIOUSNESS had to raise questions....
7. Court case will go ahead in January, 2020.... GENERICS have nothing to lose....
Mellowmood77
The motion AMARIN asked for partial summary judgement was related to depositions both parties undertook concerning OBVIOUSNESS, ANTICIPATION, ENABLEMENT, AND DEFINITIVENESSS....and generics asked for final summary judgement for AMARIN'S motion to be denied....
This new motion was submitted to the court, is asking them to rule on only on OBVIOUSNESS using prior court rulings.....or NONOBVIOUSNESS using AMARIN'S defense against OBVIOUSNESS.... like you state a possible loophole....
I would assume the court would allow AMARIN to cite additional court ruling s that would address this situation... or lack of.....
The question is what written information is required in a PATENT !!!
Bio
Does Amarin now have 30 days to reply to new Generic motion to dismiss and the court will respond 30 days after that..... thus late Oct. ruling...
You always keep us informed of court documented ruling dates
It's game of semantics...
The generics are claiming tha Amarin knew of EPA/DHA thus it was OBVIOUS when writing their patents.....since they were not the known inventor...
Generics are stating that Amarin was NONOBVIOUS of known effects, since the Marine 12 week study was done in yr 2010, when patents were written in 2008/2009 ,thus the patents have no specified results included when writing the patent ,thus patents are invalid.... yes filing an OBVIOUS claim that AMARIN was NONOBVIOUS of how the drug would perform....
But AMARIN was working with the FDA IN 2008/2009 on MARINE/ANCHOR studies with an SPA agreed upon.... so AMARIN knew potential results thru JELLIS STUDY but did not put those results in written patents...
New motion by Generics 08-30-2019.....
Generics want Amarin's MOTION for partial summary judgement denied based on....
If I get this right.... Generic's are stating that they are not claiming Amarins patents are invalid for ANTICIPATION,ENABLEMENT, OR INDEFINITENESS.... but are invalid for NONOBVIOUSNESS.....thus the three area's are moot except Obviousness....
Generics are stating that Amarins patents were written in year 2008/2009 and accepted by patent office .... but the MARINE trial was done in year 2010 and the results made the patents now OBVIOUS .... thus Amarin has no written proof that when submitting patents that the drug in fact worked...lowering tri's ,etc.
Generics are claiming that the patents are NONOBVIOUS and are invalid since no written proof was attached to patent submittal.... thus can't write a Patent if you don't know results beforehand....
Somewhere the results of the JELLIS TRIAL will emerge.....
Staying focused....
1. short interest will be published this weekend or Monday ( remember ADCOM was stated 08-08-2019.... heavy volume the following two days... will reflect volatility of SP...
2. scripts next Friday with AHA recommendation of omega 3 for vascepa/ lovaza.... will start showing whether the market understands the differentiation of both drugs...
3. court case on generic's 08-30-2019, Friday the court to rule on motions... will reflect direction and BP's will be very interested....
AtomOaks
Without a doubt you are PYRR/MRC..... the way you respond and your writing style/analysis always skewed negative...HDQ talked about summary of dates for ADCOM and you take it out of context to skew the narrative negative...
Please don't respond .... it gets old with you
PS
I meant 09-24-2018 published RRR RESULTS...
Occum's Razor = simplest truth
Why Adcom ????
trigs on top of statins = reduce-it study protocol ( yr 2013) lowers cardiovascular events...
trigs on top of statins + MOA ( METHOS OF ACTIONS )= REDUCE-IT STUDY RESULTS ON 09-24-2019
The PRIORITY REVIEW would have given us a label for lowering trigs 135/150 -500 on top of statins to reduce cardiovascular events ( per SPA ) .... but doesn't explain the final RRR in REDUCE-IT STUDY... LABEL would state ( lower's trig's and COULD lower cardiovascular events ).....
The EVAPORATE TRIAL studies the MOA which is reduction of systematic inflation which accounts for the RRR of the REDUCE-IT STUDY....
The ADCOM will concentrate on the MOA ( METHOD OF ACTION )... THE COMMITTEE will ask multitude of questions concerning VASCEPA'S results... which effects label...
The final vote could be whether they give AMARIN label for original SPA and then require AMARIN to submit a new SDNA with EVAPORATE'S results OR wait until EVAPORATE'S RESULTS come in to give the new expanded label.... FINAL QUESTION ( SHOULD WE WAIT UNTIL THE MOA IS ESTABLISHED OR GIVE AMARIN A RESTRICTED LABEL )
The FDA will work this to their benefit and it will be on JT and AMARIN to get some kind of label at the ADCOM... The FDA will protect the STATIN industry for as long as possible.....
Raf;
I made my point !!!!! and I made yours (I WILL NOT SHARE)
Raf:
Your post #208463 shows an elaborate question and possible resolution, you email to the FDA and AMARIN .....
You then respond to a poster on this board ...to responses received from FDA /AMARIN QUOTE concerning AMARIN (Amarin: I will not share that)...
You corresponded with someone in AMARIN, but post an answer that makes this board not worthy of sharing the reply??????????? what GIVES
RAF:
You submitted A QUESTION to Elizabeth (IR) and she always responds with a full response to that question..... please share that response with the board in it's entirety if you would...
RAF:
Sure you can respond concerning AMARIN'S response to this board... why bring it up otherwise!!!!
I remember you asking me the same thing concerning my posting on insider sales being halted....
You now want this board questioning your motives?????
NOTE
4days ... which means THURS.... for Federal Registry
Note
Nothing concerning AMARIN in the Federal Registry posted for tommorrrow...
tasty:
Nobody cares about the hat..... everyone can lie to each other if they want , express their own opinions, make up stories ,etc. ... BUT don't make up accusations concerning AMARIN principals/BOD or state something AMARIN falsely said when they have't communicated such.... this board can do want they want to each other, but don't involve AMARIN unless facts or truth can be presented accurately..... ONCE this happens trust is completely obliterated...
whal
I could care less about the damn hat, but how it was brought up originally wasn't truthful....
whal.....
I don't believe you have read my posts or you would know what I have done.... I have worked tirelessly for AMARIN....but what have you done directly to support AMARIN ???? not a thing....
If I remember right, just before 09-24-2018 you were predicting AMARIN less than 15%.... I believe you were 8-10% and sold you shares.... now you are JL's best friend...
you can put me on ignore, but I can't do the same, since I check to make sure what ( can't finish or removal ) what you post... your professed contrarian positions when posting says everything....
WHAL...
Another individual that slams information to suit his current position.... you've flip flopped more than anybody on this board for the last 6 yrs...
JAMES....
I never questioned that
JL was in attendance at the AHA Conference....
I stated that he he has never met any of AMARIN'S manager's or principals
personally, so ELIZABETH never presented a hat to him..... maybe someone mailed him one at his request.
NORTH.... I agree with you .... she was wearing a hat.... BUT JL was not there and she did not give him a hat.... JL plays with the truth ....
JL .... somebody may have given you a hat ,but not ELIZABETH .... She told me at the conference call, after AHA presentation, that she was not allowed near AMARIN'S booth ... I asked for her and the sales rep's said the same thing...
Wrong movie.... War games .... Matthew Broderick
Working all scenarios looking for perfect solution.... JT working all scenarios..... preparing
Game of CHESS anyone.... this line in a movie many years ago...
This board is SCHIZOPHRENIC...
Post 205496, JL states JT should NOT be replaced...
Post 205482, JL asks the $64000 question.... WHY THE SECONDARY
Post 205380, JL states I would like to see JT replaced as CEO
Thanks GreyMatter for the CHESS terminology.... per an individual in the organization .... hard to explain the PPS in the short term, but there are a lot of pieces in this PUZZLE being worked on....
Think about this analogy !!!
BIO,
Contact me on private message concerning PROGRAM DRUG issue.... I-hub preventing me ...